• Section 1 - Purpose
• Background
• Scope
• Section 2 - Policy
• Human Research Ethics Committee (HREC)
• Training
• Use of Artificial Intelligence
• Conflict of interest
• Research proposals
• Research primarily involving Aboriginal and Torres Strait Islander peoples
• Data management
• Collaborative research
• Research by external researchers involving Macquarie University students
• Ethics review services for non-Macquarie University researchers
• Monitoring and Audits of approved research
• Research outputs
• Reporting
• Compliance and Breaches
• Section 3 - Procedures
• Section 4 - Guidelines
• Section 5 - Definitions

Section 1 - Purpose

(1) This Policy outlines how Macquarie University fulfils its responsibilities for ensuring compliance with applicable codes, policies and guidelines for all research and education research projects involving human participants.

Background

(2) For research and education research projects involving human participants, the University complies with the following:

1. National Health and Medical Research Council (NHMRC);
2. Australian Research Council (ARC);
3. Universities Australia (UA) National Statement on Ethical Conduct in Human Research (National Statement),
4. Australian Code for the Responsible Conduct of Research;
5. Macquarie University Code for the Responsible Conduct for Research (The Code);
6. AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research (the AIATSIS Code); and
7. A Guide to Applying the AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research.

(3) The National Statement defines human research as research conducted with or about people, or their data or biospecimens.

(4) Human participation in research is to be understood broadly to include the involvement of human beings through:

1. taking part in surveys, interviews or focus groups;
2. undergoing psychological, physiological or medical testing or treatment;
3. being observed by researchers;
4. researchers having access to their personal documents or other materials;
5. the collection and use of their biological material as defined in the National Statement; and
6. access to their individual information in identifiable or potentially re-identifiable form as included in an unpublished source or database that is used for human research.

(5) The National Statement also notes that the term “participants” is used very broadly to include those who may not even know they are participating in research (for example, where the need for their consent for the use of their biospecimens or data has been waived by an ethics review body).

Scope

(6) The Policy applies to any person (or persons) who conducts, or assists with the conduct of, research under the auspices of Macquarie University (the University). This may include staff members (academic and professional), visiting students, visiting fellows, volunteers, honorary and adjunct title holders, Emerita/us Professors, occupational trainees and any student in a course at the University who conducts or assists with the conduct of research at or on behalf of the University.

Section 2 - Policy

(7) The University is committed to conducting its research in an ethical and accountable way to facilitate a strong and ethical research culture.

(8) The University will establish systems and processes to ensure adherence to the applicable codes, policies and guidelines for all research and education research projects involving human participants.

(9) The University will:

1. promote research that respects research participants and extends benefit to the community;
2. assist researchers in developing their research to comply with all relevant policies and legislation;
3. provide training for researchers undertaking human research;
4. maintain two Human Research Ethics Committees (HRECs), and associated terms of reference; and
5. maintain discipline specific Ethics sub-committees of the HREC and associated terms of reference.

(10) Researchers must:

1. be familiar with the guidance outlined in all sections of the National Statement;
2. conduct research in accordance with the principles of, and guidance in, the National Statement;
3. engage appropriately with communities and/or consumers that are relevant to their research and to positively engage with ethics review, governance and monitoring processes (NS:97);
4. submit their human research project for either:
   1. human research risk review if the risk level of the project is unknown; or
   2. human ethics review if the risk level of the project is known to be either low or greater than low risk;
5. independently undertake a risk assessment and risk management plan for participants and consider any risk to their own safety;
6. not begin their research project until they have final approval by either of the above pathways; and
7. identify only one Chief Investigator (CI)/Principal Investigator (PI) for each project and that CI/PI is the person with overall responsibility for the research project and must be either:
   1. continuing staff members of Macquarie University, or
   2. external to the institution with whom the University has a contractual agreement in place.

(11) Honorary and sessional staff members are not eligible to serve as Chief Investigators on research projects submitted for ethics review. Fixed-term Macquarie University staff members may be permitted with some exceptions Further advice can be sought by emailing: ethics.secretariat@mq.edu.au.

(12) Approval of Human Research Ethics applications does not equate to approval to proceed. All relevant processes, institutional approvals or authorisations must be completed or granted before the research commences.

Human Research Ethics Committee (HREC)

(13) The University maintains two Human Research Ethics Committees:

1. the Humanities and Social Science HREC reviews research proposals in social science, business, and humanities disciplines; and
2. the Medical and Health Science HREC reviews medical and health research, including all clinical trial research.

(14) HREC committees will convene regular meetings (10 times annually) to conduct thorough ethics reviews.

(15) Human Research Ethics sub-committees will provide expedited review of low-risk ethics applications on a rolling basis to ensure timely processing of lower-risk research proposals.

Training

(16) Researchers must complete the Introduction to Human Research Ethics training module prior to submitting an ethics application. Staff members can access the training via Workday. Postgraduate and undergraduate students can access the training via iLearn.

Use of Artificial Intelligence

(17) Artificial Intelligence (AI) may be used as a supportive tool to enhance the quality and clarity of ethics applications, provided academic integrity is maintained and researchers take full responsibility for all content.

(18) Researchers must ensure the use of AI delivers "positive results" and "meaningful benefits" per the Responsible and Ethical Use of Artificial Intelligence Policy while also adhering to the Academic Integrity Policy and the Macquarie University Code for the Responsible Conduct of Research.

(19) All AI-generated content must be thoroughly reviewed, verified, and personalised to accurately reflect the research proposal and demonstrate a genuine understanding of the ethical considerations involved (refer to the Responsible and Ethical Use of Artificial Intelligence Policy).

(20) Researchers remain fully accountable for all content and must exercise human oversight over any AI-generated output, ensuring all information accurately represents the proposed research.

(21) Disclosure of AI assistance may be required, and its use must align with supporting legitimate academic work while demonstrating genuine understanding of the ethical issues of the research.

Conflict of interest

(22) Researchers must disclose any actual, potential or perceived conflict of interest, including any financial or other interest or affiliation that relates to the research.

(23) The HRECs will manage committee members’ conflicts of interest by excluding them from any discussion of their application and noting the conflict in the committee minutes.

Research proposals

(24) The University will:

1. maintain mechanisms to review all research proposals and education research projects involving human participants;
2. take reasonable steps so that any identified risks to participants are managed appropriately; and
3. establish procedures for monitoring approved research to ensure that all research projects conform with ethics standards outlined in the National Statement.

(25) To facilitate a thorough ethics assessment, researchers must:

1. provide comprehensive documentation of:
   1. research projects;
   2. participant information;
   3. any relevant risk mitigation strategies; and
   4. any other documentation relevant to their research project;  
2. not deviate from approved projects without prior authorisation by submitting an amendment request;
3. promptly report any adverse events, project amendments, project deviations or unforeseen ethical issues to the ethics review body; and
4. comply with monitoring and reporting requirements as stipulated by the ethics review body to ensure the ongoing ethical conduct of research. 

(26) Applications can be amended at any time, even after final approval has been received by using correspondence in project via the FoRA System.

(27) Amendments to approved projects cannot, however, be implemented until approved by the appropriate Human Research Ethics Committee or its sub-committees.

Research primarily involving Aboriginal and Torres Strait Islander peoples

(28) Per the National Statement, researchers planning to undertake any type of research with Aboriginal and Torres Strait Islander people and communities must consult and follow the advice in the most contemporary versions of the following:

1. NHMRC's Ethical Conduct in Research with Aboriginal and Torres Strait Islander Peoples and Communities: Guidelines for Researchers and Stakeholders (2018);
2. Keeping Research on Track II (2018);
3. AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research (2020); and
4. A Guide to Applying the AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research (2020) produced by the Australian Institute of Aboriginal and Torres Strait Islander Studies (AIATSIS).

(29) These guidelines embody the best standards of ethical research and human rights and seek to ensure that research with and about Aboriginal and Torres Strait Islander people and communities follows a process of meaningful engagement and reciprocity between the researcher and the individuals and/or communities involved in the research.

Data management

(30) Researchers must maintain comprehensive records of their research in accordance with their approved protocol and data management plan, as required by the National Statement and in compliance with the University's Research Data Management Policy and Framework.

(31) All data collection, storage, retention, disposal, sharing and re-use activities must follow the security arrangements and procedures specified in their ethics-approved data management plan to ensure participant privacy and data integrity throughout the research lifecycle.

Collaborative research

(32) The University encourages collaborative research both domestically and internationally. Where research has already received ethics approval from another institution, duplication of an ethics review should be minimised in accordance with the National Statement.

(33) Research that has already received ethics approval from another recognised ethics committee only requires an additional Macquarie University ethics review if researchers will be collecting data or recruiting participants at the University.

(34) Where an additional ethics review is required under clause 33, researchers must submit an External Approval Ethics Form (EAEF) in accordance with the EAEF Applicant Guide.

(35) In accordance with the National Statement the University will accept external ethics approvals, including those from international review bodies, provided that:

1. Macquarie University researchers are named on the original ethics application;
2. researchers provide evidence of ethics approval; and
3. for international review bodies (IRB), a copy of the National Standards or equivalent ethical framework under which they review ethics is provided to enable the University to determine on a case-by-case basis that the external review body follows the same fundamental principles as the National Statement.

(36) All IRB approvals will be assessed individually to ensure they demonstrate equivalent ethical standards based on the principles of research merit and integrity, justice, beneficence, and respect for human beings, and provide adequate evidence of proper ethical oversight that meets the University's standards for protecting research participants.

(37) The Human Research Ethics Secretariat will initially assess IRB approvals and determine their acceptability in accordance with this Policy. If the outcome is unclear, it will be escalated to the Director, Research Ethics and Integrity.

Research by external researchers involving Macquarie University students

(38) The University receives requests from external researchers to access University students and staff for research purposes. While the University supports legitimate research that contributes to knowledge and benefits the community, it must ensure appropriate governance processes are in place to protect student welfare and maintain academic operations.

(39) The University does not provide ethics review services for external researchers working with Macquarie University students. External researchers must obtain ethics approval from their home institution's Human Research Ethics Committee or another appropriately constituted ethics review body prior to requesting approval to access University participants.

(40) The requirement for approval of undertaking research involving Macquarie University students by external third parties depend on the scale and scope of the proposed research.

(41) Research involving no direct contact with students, such as a single online survey that is not specifically targeting Macquarie University students and is not advertised via Macquarie University-specific channels or on Macquarie University campus, does not require separate governance approval from Macquarie University (though external ethics approval remains mandatory).

(42) Extensive research involving multiple data collection points, face-to-face interactions, access to University facilities, or specific targeting of Macquarie University students will require separate Macquarie University governance approval.

(43) Given that each Faculty has different requirements based on varying student priorities and academic considerations, external researchers should make initial contact with the relevant Head of School or Faculty to determine specific approval requirements and processes.

(44) The approval process will assess whether the proposed research:

1. aligns with University priorities and academic objectives;
2. ensures adequate protection of student welfare;
3. minimises research fatigue within the University community; and
4. complies with University policies regarding data protection and participant privacy.

(45) The University reserves the right to decline external research requests that do not meet institutional standards or that may compromise student wellbeing.

(46) All approved research must comply with University policies regarding data protection, participant privacy, and research governance requirements.

Ethics review services for non-Macquarie University researchers

(47) The University may provide ethics review services to external organisations and researchers who do not have access to an appropriately constituted HREC, subject to resource availability and alignment with University standards.

(48) Ethics review services may be provided to external entities on a fee-for-service basis only where:

1. the University has an existing contractual agreement or formal arrangement with the external entity; or
2. the proposed research aligns with University research priorities, policies, and ethical standards; and
3. the external entity demonstrates they do not have access to an appropriately constituted HREC within their own organisation.

(49) All ethics review services for external entities are provided on a fee-for-service basis in accordance with the Macquarie University HREC published fee schedule.

(50) Fees are payable upon review of a submission and are charged at the discretion of the Director, Research Ethics and Integrity.

(51) External ethics review services are subject to:

1. availability of Human Research Ethics Committee resources and capacity;
2. the proposed research meeting University ethical standards and policy requirements;
3. the research not conflicting with University research priorities or creating reputational risks; and
4. compliance with all relevant University policies regarding data protection, participant privacy, and research governance.

(52) The Director, Research Ethics and Integrity has discretionary authority to accept or decline external applications based on resource availability, alignment with University standards, and institutional priorities.

(53) The University reserves the right to discontinue external ethics review services where they compromise the Committee's ability to serve University staff and students or where they conflict with University interests.

Monitoring and Audits of approved research

(54) The HRECs may employ a variety of approaches to monitor approved research, this may include, but is not limited to, internal audits of documentation, inspection of sites, interviews or meetings with researchers. Researchers are expected to assist in these monitor activities when requested.

(55) The University has the primary responsibility for ensuring that approved research is conducted in accordance with ethical standards and maintains systematic monitoring processes to verify compliance with approved protocols and the National Statement requirements.

(56) The University conducts regular monitoring of approved human research through:

1. annual and final progress reports from researchers;
2. systematic human research ethics audits;
3. review of adverse events and safety reports; and
4. compliance audits on research that has had ethics approval.

(57) Compliance audits may be initiated:

1. on a thematic basis to examine specific research methodologies, participant populations, or compliance areas across multiple projects;
2. following receipt of complaints about research from participants, community members, or other stakeholders;
3. in response to safety reports or institutional concerns about research practices; or
4. through random sampling of approved research projects as part of quality assurance processes.

(58) Researchers found to be non-compliant with approved protocols or ethical requirements must develop and implement Corrective and Preventive Action (CAPA) plans that:

1. address all identified deficiencies within specified timeframes;
2. include appropriate monitoring mechanisms to ensure effectiveness; and
3. receive formal approval through the amendment process before implementation.

(59) All research activities under audit must be suspended immediately upon audit initiation and cannot resume until audit procedures are completed, findings are reviewed by the HREC, and any required corrective actions are implemented and approved.

Research outputs

(60) In research outputs associated with HREC approval, researchers must include a statement identifying the institutional or licensing committee that approved the research. This statement should include the relevant code for the approved application/protocol.

Reporting

(61) The University will provide regular reports to the Deputy Vice-Chancellor (Research), the Vice-Chancellor, the NHMRC and the Information and Privacy Commission NSW.

Compliance and Breaches

(62) Alleged breaches of this Policy and non-compliance by a researcher will be managed in accordance with the Macquarie University Research Code Complaints, Breaches and Investigation Procedure, which provides a framework for:

1. receiving and assessing complaints about research conduct;
2. determining whether allegations constitute breaches of research integrity standards;
3. conducting fair and thorough investigations where required; and
4. implementing appropriate corrective actions and sanctions.

(63) Where audit findings or breach investigations identify systemic issues or serious non-compliance, the matter may be referred to relevant authorities including the institutional research integrity processes, or external regulatory bodies as appropriate.

(64) The University may conduct follow-up monitoring including investigations, progress reviews, or enhanced reporting requirements to verify successful implementation of corrective actions and prevent recurrence of non-compliance.

Section 3 - Procedures

(65) Nil.

Section 4 - Guidelines

(66) Nil.

Section 5 - Definitions

(67) The following definitions apply for the purpose of this Policy:

1. Australian Research Council (ARC) is the primary non-medical research funding agency of the Australian Government.
2. IRB means an International Review Body that reviews research for ethics compliance
3. National Health and Medical Research Council (NHMRC) means Australia’s peak body for supporting health and medical research; for developing health advice for the Australian community, health professionals and governments; and for providing advice on ethical behaviour in health care and in the conduct of health and medical research.
4. National Statement means the National Statement on Ethical Conduct in Human Research. The National Statement clarifies the responsibilities of institutions, researchers and review bodies for the ethical design, review, conduct, and dissemination of results of human research.
5. The Code means the Australian Code for the Responsible Conduct of Research, 2018. The Code provides guidance to institutions and researchers in responsible research practices.
6. The Macquarie University Code means the Macquarie University Code for the Responsible Conduct of Research. The Macquarie University Code outlines standards of responsible and ethical conduct expected of all persons engaged in research under the auspices of Macquarie University.
7. Universities Australia (UA) the peak body for the Australian University sector.